[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533181":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":45,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":26,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":26,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients treat with Dorzagliatin","EXPERIMENTAL","Dorzagliatin will be initiated and maintained at 75mg twice a day until the completion of the study. Meanwhile, all patients will also continue on regimen of metformin 500mg three times a day throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs.",[13],"Drug: Dorzagliatin",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients treat with Gliclazide","ACTIVE_COMPARATOR","Gliclazide will be initiated and maintained at 30mg once a day until the completion of the study. Meanwhile, all patients will also continue on regimen of metformin 500mg three times a day throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs.",[19],"Drug: Gliclazide",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dorzagliatin","Dorzagliatin will be initiated and maintained at 75mg twice a day",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Gliclazide","Gliclazide will be initiated and maintained at 30mg once a day",[15],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":26},"Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University","Nanjing","Jiangsu","210008","China","CN",{"type":40,"coordinates":41},"Point",[42,43],118.77778,32.06167,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Yan Bi","Chief Physician","100533181","effect-of-dorzagliatin-on-renal-function-outcomes-in-people-with-type-2-diabetes-a-multicentric-prospective-randomized-study-100533181",false,"NCT06222476","Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.","A Multicentric, Prospective, Randomized Study Evaluating the Improvement of Renal Function Outcomes With Dorzagliatin in Patients With Type 2 Diabetes Mellitus With Early Kidney Injury.","Inclusion Criteria:\n\n1. Age:18-75 years old, male and female.\n2. Patients with type 2 diabetes mellitus, type 2 diabetes mellitus diagnosis criteria: according to the \"Chinese Type 2 Diabetes Mellitus Prevention and Treatment Guide (2020 Edition).\n3. UACR 30-299mg\u002Fg.\n4. eGFR ≥60mL\u002Fmin\u002F1.73m².\n5. HbA1c 7.0-10.5%.\n\nExclusion Criteria:\n\n1. Pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures.\n2. Known allergic history to dorzagliatin\u002Fgliclazide\u002Fmetformin.\n3. Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc.\n4. Serious impairment of heart, liver, kidney and other organs.\n5. With hypertension(≥140\u002F90mmHg).\n6. Fasting C-peptide \\\u003C300pmol\u002FL.\n7. Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc.","ALL","18 Years","75 Years",{"count":60,"type":61},106,"ESTIMATED","INTERVENTIONAL",[64],"NA","The main purpose of this study is to explore the improvement of renal function before and after the intervention of dorzagliatin in patients with type 2 diabetes.",[67],"Diabetic Nephropathy Type 2","NOT_YET_RECRUITING","2024-01-16",{"date":71,"type":72},"2024-01-24","ACTUAL",{"date":74,"type":61},"2024-02-20",{"date":76,"type":61},"2026-06-30",{"name":47,"class":6},1]